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

Cancer Clinical Trial

— ROSY-D  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05303532
• Other study ID #: D4191C00137
• Secondary ID: 2021-003031-29
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 19, 2022
• Est. completion date: May 8, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 61
• Est. completion date: May 8, 2025
• Est. primary completion date: May 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

• Patient can receive durvalumab as a fixed dose of 1500 mg quarterly 4 weeks at study entry.

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 (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 [example: Response Evaluation Criteria in Solid Tumours] progression or clinical 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.

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Drug:
• Durvalumab
Fixed dose of 1500 mg via IV infusion upon enrollment visit and every 4 weeks thereafter.

Locations

Country	Name	City	State
Argentina	Research Site	Rosario
Australia	Research Site	Box Hill
Australia	Research Site	Melbourne
Belgium	Research Site	Charleroi
Brazil	Research Site	Barretos
Brazil	Research Site	Porto Alegre
Brazil	Research Site	São José do Rio Preto
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Toronto	Ontario
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changsha
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Hangzhou
China	Research Site	Jinan
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shijiazhuang
China	Research Site	Xi'an
China	Research Site	Xi'an
Czechia	Research Site	Olomouc
France	Research Site	Besançon Cedex
France	Research Site	Bordeaux Cedex
France	Research Site	Brest
France	Research Site	Dijon cedex
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Rouen
France	Research Site	Saint Herblain
France	Research Site	Strasbourg
France	Research Site	Toulouse Cedex 09
France	Research Site	Tours CEDEX
France	Research Site	Villejuif
Germany	Research Site	Guetersloh
Germany	Research Site	Muenster
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Székesfehérvár
India	Research Site	Chennai
Italy	Research Site	Arezzo
Italy	Research Site	Bari
Italy	Research Site	Catania
Italy	Research Site	Meldola
Italy	Research Site	Milan
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Padova
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Roma
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Kanazawa-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Nagasaki-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Saga-shi
Japan	Research Site	Sunto-gun
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Malaysia	Research Site	Kuching
Poland	Research Site	Bialystok
Poland	Research Site	Lódz
Poland	Research Site	Lódz
Poland	Research Site	Olsztyn
Poland	Research Site	Szczecin
Romania	Research Site	Suceava
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Girona
Spain	Research Site	Madrid
Spain	Research Site	Marbella
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Valencia
Switzerland	Research Site	Lausanne
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Taoyuan
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Hat Yai
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Bursa
Turkey	Research Site	Çankaya
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Ukraine	Research Site	Chernivtsi
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Uzhhorod
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	London
United Kingdom	Research Site	Sheffield
United States	Research Site	Houston	Texas
United States	Research Site	Memphis	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh city

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Czechia,  France,  Germany,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	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).	From baseline up to follow up at 90 days after the last dose of study drug.