Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab

Ki vehet részt

• Provision of signed and dated, written ICF
• Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study's protocol
• Patient can receive durvalumab as a fixed dose of 1500 mg Q4W at study entry

Ki nem vehet részt

• Core Protocol exclusion criteria: Currently receiving treatment with any prohibited medication(s)
• Core Protocol exclusion criteria: Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation
• Additional exclusion criteria for the ROSY-D sub-study: Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of ≤ 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study
• Core Protocol exclusion criteria: Permanent discontinuation from the parent study due to toxicity or disease progression (increase in the severity of the disease under study and/or increases in the symptoms of a patient’s condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, Response Evaluation Criteria in Solid Tumours] progression or clinical progression)
• Additional exclusion criteria for the ROSY-D sub-study: Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies)
• Core Protocol exclusion criteria: Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study
• Core Protocol exclusion criteria: Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Additional exclusion criteria for the ROSY-D sub-study: Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy