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.
Patients eligible for the study drug according to the approved label in Korea
Provision of a signed and dated written informed consent by the patient or their legally acceptable representative
Participation in any concurrent interventional trials during the period of the study drug treatment
Other off-label indications according to the approved label in Korea
Patients will be enrolled by a total surveillance method. In principle, patients treated with study drugs in accordance with local prescribing information are eligible for enrollment in this study. Each patient must meet all of the inclusion criteria and none of the exclusion criteria. Investigators should enroll the patients who initiate or are receiving treatment with study drugs after the contract date.
Cohort
Prospective
Not listed
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Real-world Progression free survival (rwPFS)
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
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