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

Study identifier:D4191C00137

ClinicalTrials.gov identifier:NCT05303532

EudraCT identifier:2021-003031-29

CTIS identifier:N/A

Recruiting

Official Title

ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

Medical condition

cancer

Phase

Phase 3

Healthy volunteers

Study drug

Durvalumab

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 19 Apr 2022

Estimated Primary Completion Date: 08 May 2025

Estimated Study Completion Date: 08 May 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

The Core Protocol inclusion criteria are:
- Provision of signed and dated, written Informed Consent Form (ICF).
- Patient is currently deriving clinical benefit, as judged by the investigator, from continued treatment in an AstraZeneca parent study using an AstraZeneca 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.
There are no additional inclusion criteria for the ROSY-D sub-study.

Exclusion Criteria

The Core Protocol exclusion criteria are.
- Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
- Currently receiving treatment with any prohibited medication(s).
- Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Permanent discontinuation from the parent study due to toxicity or disease progression.
- Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.
The additional exclusion criteria for the ROSY-D sub-study are:
- Active infection including Coronavirus disease 2019 (Polymerase chain reaction confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive Hepatitis B virus (HBV) surface antigen result), hepatitis C, or Human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).
- 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.
- 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, per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

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No locations available

Arms	Assigned Interventions
Experimental: Durvalumab Participants will receive durvalumab.	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]