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

Sponsor

AstraZeneca (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05303532

Collaborator

(none)

Enrollment

Locations

Arm

30.7

Anticipated Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer Urothelial Carcinoma	Drug: Durvalumab	Phase 3

Detailed Description

ROSY-D is an open label, non-randomised, multicentre, international trial for patients who have completed a parent study using durvalumab and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 19, 2022

Anticipated Primary Completion Date :

Nov 8, 2024

Anticipated Study Completion Date :

Nov 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Durvalumab Participants will receive durvalumab.	Drug: Durvalumab Fixed dose of 1500 mg via IV infusion upon entry and every 4 weeks thereafter.

Arm

Intervention/Treatment

Experimental: Durvalumab

Participants will receive durvalumab.

Drug: Durvalumab

Fixed dose of 1500 mg via IV infusion upon entry and every 4 weeks thereafter.

Outcome Measures

Primary Outcome Measures

Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [From baseline up to follow up at 90 days after the last dose of study drug.]
To monitor safety and tolerability of continuous study treatment to patients who continue to benefit at the end of the clinical trial by measuring the primary outcome of Serious Adverse Events (SAEs).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 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.

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, as per Toxicity Dose Modification and TMGs for Immune- mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Newmarket	Ontario	Canada	L3Y 2P9
2	Research Site	Besançon Cedex		France	25030
3	Research Site	Bordeaux Cedex		France	33076
4	Research Site	Brest		France	29200
5	Research Site	Dijon cedex		France	21079
6	Research Site	Lyon		France	69373
7	Research Site	Marseille		France	13005
8	Research Site	Montpellier		France	34090
9	Research Site	Pierre Benite		France	69495
10	Research Site	Rouen		France	76031
11	Research Site	Saint Herblain		France	44805
12	Research Site	Strasbourg		France	67091
13	Research Site	Tours CEDEX		France	37044
14	Research Site	Villejuif		France	94805
15	Research Site	Guetersloh		Germany	33332
16	Research Site	Muenster		Germany	48149
17	Research Site	Arezzo		Italy	52100
18	Research Site	Catania		Italy	95126
19	Research Site	Meldola		Italy	47014
20	Research Site	Milan		Italy	20141
21	Research Site	Padova		Italy	35128
22	Research Site	Pisa		Italy	56126
23	Research Site	Roma		Italy	00128
24	Research Site	Roma		Italy	00152
25	Research Site	Busan		Korea, Republic of	49241
26	Research Site	Seoul		Korea, Republic of	6351
27	Research Site	Sheffield		United Kingdom	S10 2SJ