Endometrial Neoplasms Clinical Trial
— DUO-EOfficial title:
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
| Verified date | March 2024 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | The European Network for Gynaecological Oncological Trial groups (ENGOT), The Gynecologic Oncology Group (GOG) Foundation Inc |
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,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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