Getwell Hospital & Research Institute | Research Site
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
805 participants in 3 patient groups
Loading...
Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal