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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04269200
Other study ID # D9311C00001
Secondary ID GOG-3041ENGOT-EN
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 5, 2020
Est. completion date March 5, 2025

Study information

Verified date March 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 805
Est. completion date March 5, 2025
Est. primary completion date March 5, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 150 Years
Eligibility 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: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. 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 and there is at least 12 months from date of last dose of systemic anti-cancer treatment 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. - Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
olaparib
Olaparib tablets
Biological:
durvalumab
Durvalumab by intravenous infusion
Drug:
durvalumab placebo
Matching placebo for intravenous infusion
olaparib placebo
Placebo tablets to match olaparib
Carboplatin
Standard of care chemotherapy
Paclitaxel
Standard of care chemotherapy

Locations

Country Name City State
Australia Research Site Clayton
Australia Research Site Malvern
Australia Research Site Melbourne
Australia Research Site Nedlands
Australia Research Site Sydney
Belgium Research Site Bruges
Belgium Research Site Bruxelles
Belgium Research Site Charleroi
Belgium Research Site Gent
Belgium Research Site Hasselt
Belgium Research Site Kortrijk
Belgium Research Site Leuven
Belgium Research Site Libramont-Chevigny
Belgium Research Site Liège
Brazil Research Site Belo Horizonte
Brazil Research Site Belo Horizonte
Brazil Research Site Curitiba
Brazil Research Site Passo Fundo
Brazil Research Site Pelotas
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Porto Alegre
Brazil Research Site Rio de Janeiro
Brazil Research Site São José do Rio Preto
Brazil Research Site Sao Paulo
Brazil Research Site Sao Paulo
Canada Research Site Calgary Alberta
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
China Research Site Beijing
China Research Site Beijing
China Research Site Changchun
China Research Site Changchun
China Research Site Changsha
China Research Site Changsha
China Research Site Chengdu
China Research Site Chongqing
China Research Site Chongqing
China Research Site Dalian
China Research Site Dalian
China Research Site Guangdong
China Research Site Guangzhou
China Research Site Haikou
China Research Site Harbin
China Research Site Hefei
China Research Site Nanning
China Research Site Shanghai
China Research Site Shenyang
China Research Site Taiyuan
China Research Site Tianjin
China Research Site Wuhan
China Research Site Wuhan
China Research Site Zhanjiang
China Research Site Zhengzhou
China Research Site Zhengzhou
Colombia Research Site Barranquilla
Colombia Research Site Bogota
Colombia Research Site Bogota
Colombia Research Site Bogota
Colombia Research Site Cali
Colombia Research Site Medellin
Colombia Research Site Medellín
Colombia Research Site Monteria
Colombia Research Site Pereira
Estonia Research Site Tallinn
Estonia Research Site Tartu
Germany Research Site Bonn
Germany Research Site Chemnitz
Germany Research Site Dresden
Germany Research Site Leipzig
Greece Research Site Athens
Greece Research Site Chaidari
Greece Research Site Thessaloniki
Hong Kong Research Site HKG
Hong Kong Research Site Hong Kong
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Debrecen
Hungary Research Site Gyor
Hungary Research Site Szolnok
India Research Site Hisar
India Research Site Mumbai
Israel Research Site Be'er Ya'akov
Israel Research Site Hadera
Israel Research Site Jerusalem
Israel Research Site Nahariya
Israel Research Site Tel Aviv
Japan Research Site Chuo-ku
Japan Research Site Kashiwa-shi
Japan Research Site Koto-ku
Japan Research Site Kurume-shi
Japan Research Site Kyoto-shi
Japan Research Site Matsuyama-shi
Japan Research Site Minato-ku
Japan Research Site Nagoya-shi
Japan Research Site Nakagami-gun
Japan Research Site Niigata-shi
Japan Research Site Osaka
Japan Research Site Osaka-shi
Japan Research Site Sapporo-shi
Japan Research Site Shinjuku-ku
Japan Research Site Sunto-gun
Japan Research Site Toon-Shi
Japan Research Site Tsu-shi
Japan Research Site Yokohama-shi
Korea, Republic of Research Site Goyang-si
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Suwon
Korea, Republic of Research Site Yangsan-si
Lithuania Research Site Kaunas
Lithuania Research Site Vilnius
Lithuania Research Site Vilnius
Mexico Research Site Aguascalientes
Mexico Research Site Mexico
Mexico Research Site Monterrey
Mexico Research Site Oaxaca
Mexico Research Site Queretaro
Mexico Research Site San Luis Potosi
Mexico Research Site Veracruz
Poland Research Site Gdansk
Poland Research Site Lódz
Poland Research Site Lublin
Poland Research Site Olsztyn
Poland Research Site Olsztyn
Russian Federation Research Site Anzorey
Russian Federation Research Site Kazan, Tatarstan
Russian Federation Research Site Krasnodar
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saransk
Russian Federation Research Site Sochi
Russian Federation Research Site St. Petersburg
Singapore Research Site Singapore
Singapore Research Site Singapore
Singapore Research Site Singapore
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site El Palmar
Spain Research Site Girona
Spain Research Site Jaén
Spain Research Site Madrid
Spain Research Site Mallorca
United States Research Site Arlington Heights Illinois
United States Research Site Aurora Colorado
United States Research Site Baton Rouge Louisiana
United States Research Site Bedford Texas
United States Research Site Boston Massachusetts
United States Research Site Camden New Jersey
United States Research Site Chattanooga Tennessee
United States Research Site Chicago Illinois
United States Research Site Cleveland Ohio
United States Research Site Cleveland Ohio
United States Research Site Concord California
United States Research Site Dallas Texas
United States Research Site Dayton Ohio
United States Research Site Eugene Oregon
United States Research Site Fairfax Virginia
United States Research Site Fort Lauderdale Florida
United States Research Site Germantown Tennessee
United States Research Site Honolulu Hawaii
United States Research Site Houston Texas
United States Research Site Indianapolis Indiana
United States Research Site Jackson Mississippi
United States Research Site Knoxville Tennessee
United States Research Site La Jolla California
United States Research Site Lebanon New Hampshire
United States Research Site Louisville Kentucky
United States Research Site Madison Wisconsin
United States Research Site Milwaukee Wisconsin
United States Research Site Morgantown West Virginia
United States Research Site New York New York
United States Research Site New York New York
United States Research Site Norfolk Virginia
United States Research Site Oklahoma City Oklahoma
United States Research Site Paramus New Jersey
United States Research Site Pinehurst North Carolina
United States Research Site Pittsburgh Pennsylvania
United States Research Site Providence Rhode Island
United States Research Site Saint Paul Minnesota
United States Research Site San Antonio Texas
United States Research Site San Francisco California
United States Research Site Santa Barbara California
United States Research Site Savannah Georgia
United States Research Site Seattle Washington
United States Research Site Sioux Falls South Dakota
United States Research Site Sugar Land Texas
United States Research Site Tampa Florida
United States Research Site Tigard Oregon
United States Research Site Tucson Arizona
United States Research Site Tulsa Oklahoma
United States Research Site Tyler Texas
United States Research Site Webster Texas

Sponsors (3)

Lead Sponsor Collaborator
AstraZeneca The European Network for Gynaecological Oncological Trial groups (ENGOT), The Gynecologic Oncology Group (GOG) Foundation Inc

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Colombia,  Estonia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Lithuania,  Mexico,  Poland,  Russian Federation,  Singapore,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A Defined as the time from randomisation until the date of objective disease progression (per RECIST 1.1 as assessed by investigator) or death (by any cause in the absence of progression) Up to 4 years
Secondary Second Progression (PFS2) Defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause Up to 6 years
Secondary Overall Survival (OS) Defined as the time from randomisation to death due to any cause Up to 6 years
Secondary Objective Response Rate (ORR) Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site. Up to 4 years
Secondary Duration of response (DoR) Defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression Up to 4 years
Secondary Time to first subsequent therapy (TFST) Defined as the time from randomisation to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment or death due to any cause Up to 6 years
Secondary Time to second subsequent therapy (TSST) Defined as the time from randomisation to the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment or death due to any cause. Up to 6 years
Secondary Time to discontinuation or death (TDT) Defined as the time from randomisation to the earlier of the date of study treatment discontinuation or death. Up to 6 years
Secondary The pharmacokinetics (PK) of durvalumab will be determined after steady state doses Determination of durvalumab concentration in serum Up to 4 years
Secondary Safety and tolerability of drugs by assessment of AEs/SAEs Graded according to the National Cancer Institute (NCI CTCAE) Up to 6 years
Secondary The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum Up to 4 years
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