Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT06995833
Brief Summary:
Objectives of this study are to assess the safety and effectiveness of Durvalumab with or without Olaparib (hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug under the approved indication in Korea.
This is a multicenter, prospective, observational, real world treatment study. Patients treated as part of routine practice at Korean healthcare centers by investigators will be identified and considered for inclusion in the study. The period of this study is expected to run for 4 years from the approval date of the indication for this study. Approximately 50 patients are expected to be enrolled during the study.
Patient will be followed for approximately 12 months from the first dose or up to 90 days after treatment discontinuation if the study drug is administered for less than 12 months, unless they withdraw consent, are lost to follow-up or death.
Detailed Description:
Primary Objective: To assess the safety of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea
Secondary Objective: To assess effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea
Exploratory Objective: To assess the safety and effectiveness of the study drug in patients prescribed with the study drug under the approved indication(s) in Korea by treatment/ MMR status
Study:
NCT06995833
Study Brief:
Protocol Section:
NCT06995833