DURVALUMAB for Endometrial cancer

Inclusion criteria

• {"criterion_text":"- Age ≥18 years at the time of screening and female.\n- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.\n- Patient must have endometrial cancer in one of the following categories: a) Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), b) Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) c) 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.\n- 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 (as part of the upfront/adjuvant anti-cancer treatment, which may be concurrent or followed with chemoradiation) and there is at least 12 months from date of last dose of chemotherapy administered to date of subsequent relapse.\n- FPPE tumor sample must be available for MMR evaluation.\n- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment."}

Exclusion criteria

• {"criterion_text":"- History of leptomeningeal carcinomatosis\n- Brain metastases or spinal cord compression.\n- Prior treatment with PARP inhibitors.\n- Prior immune-mediated therapy including other anti-CTLA-4, anti-PD-1, anti-PD-L1 or anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines\""}

Primary endpoints

• {"endpoint_text":"- PFS (per RECIST 1.1 as assessed by investigator) is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression).","definition_or_measurement_approach":"Per RECIST 1.1 as assessed by investigator; defined as time from randomisation to objective disease progression or death (by any cause in the absence of progression)."}

Secondary endpoints

• {"endpoint_text":"- PFS2: Second progression-free survival is 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.","definition_or_measurement_approach":"Time from randomisation to earliest progression after first subsequent therapy or death; assessed by investigator per local standard clinical practice (may include objective radiological imaging or symptomatic progression)."}
• {"endpoint_text":"- OS: Overall survival is defined as the time from the date of randomisation until death due to any cause.","definition_or_measurement_approach":"Time from randomisation until death due to any cause."}
• {"endpoint_text":"- ORR: Objective response rate is 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.","definition_or_measurement_approach":"Proportion of patients with confirmed CR or PR among those with measurable disease at baseline as determined by investigator at local site."}
• {"endpoint_text":"- DoR: Duration of response is time from the date of first documented response (subsequently confirmed) until date of documented progression or death in the absence of disease progression, as determined by the investigator at local site.","definition_or_measurement_approach":"Time from first documented (and subsequently confirmed) response until documented progression or death in absence of progression; determined by investigator at local site."}
• {"endpoint_text":"- TFST: Time to first subsequent therapy or death is time from randomisation to the earlier of start date of the first subsequent anticancer therapy after discontinuation of randomised treatment or death due to any cause.","definition_or_measurement_approach":"Time from randomisation to earlier of start of first subsequent anticancer therapy after discontinuing randomised treatment or death."}
• {"endpoint_text":"- TSST: Time to second subsequent therapy or death is time from randomisation to the earlier of start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment or death due to any cause.","definition_or_measurement_approach":"Time from randomisation to earlier of start of second subsequent anticancer therapy after discontinuation of first subsequent treatment or death."}
• {"endpoint_text":"- TDT: Time to study treatment discontinuation or death is time from randomisation to the earlier of the date of study treatment discontinuation or death.","definition_or_measurement_approach":"Time from randomisation to earlier of date of study treatment discontinuation or death."}
• {"endpoint_text":"- Serum concentrations of durvalumab","definition_or_measurement_approach":"Measured serum concentrations of durvalumab (PK assessment)."}
• {"endpoint_text":"- Anti-drug antibodies (ADA) to durvalumab","definition_or_measurement_approach":"Measurement of anti-drug antibodies to durvalumab (immunogenicity assessment)."}
• {"endpoint_text":"- Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), physical examination, vital signs including blood pressure, pulse, clinical laboratory including clinical chemistry/haematology parameters, and ECG","definition_or_measurement_approach":"Safety assessed by AEs/SAEs, physical exams, vital signs, clinical laboratory (chemistry/haematology), and ECG."}

Estonia

Latest Decision Or Authorization Date

05-09-2025

Number Of Sites

1

Number Of Participants

4

Poland

Latest Decision Or Authorization Date

08-09-2025

Number Of Sites

5

Number Of Participants

20

Lithuania

Latest Decision Or Authorization Date

03-09-2025

Number Of Sites

1

Number Of Participants

9

Belgium

Latest Decision Or Authorization Date

03-09-2025

Number Of Sites

6

Number Of Participants

28

Hungary

Latest Decision Or Authorization Date

05-09-2025

Number Of Sites

3

Number Of Participants

13

Greece

Latest Decision Or Authorization Date

02-09-2025

Number Of Sites

2

Number Of Participants

22

Spain

Latest Decision Or Authorization Date

05-11-2025

Number Of Sites

4

Number Of Participants

16

Germany

Latest Decision Or Authorization Date

05-01-2026

Number Of Sites

1

Number Of Participants

4

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Third parties

• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes: 1,10,11,12,2,4,5,7,8,9","organisation_type":"Pharmaceutical company"}