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

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [Time frame: From baseline up to follow up at 90 days after the last dose of study drug.]

Eligibility 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

France · 14 centers

• Research Site — Besançon
• Research Site — Bordeaux
• Research Site — Brest
• Research Site — Dijon
• Research Site — Lyon
• Research Site — Marseille
• Research Site — Montpellier
• Research Site — Rennes
• … and 6 more centers

China · 10 centers

• Research Site — Beijing
• Research Site — Changsha
• Research Site — Hangzhou
• Research Site — Hangzhou
• Research Site — Nanjing
• Research Site — Shanghai
• Research Site — Shenyang
• Research Site — Wenzhou
• … and 2 more centers

Italy · 10 centers

• Research Site — Arezzo
• Research Site — Bari
• Research Site — Catania
• Research Site — Meldola
• Research Site — Milan
• Research Site — Modena
• Research Site — Padova
• Research Site — Pisa
• … and 2 more centers

Japan · 8 centers

• Research Site — Bunkyō City
• Research Site — Fukuoka
• Research Site — Kanazawa
• Research Site — Kōtoku
• Research Site — Nagoya
• Research Site — Okayama
• Research Site — Saga
• Research Site — Sunto-gun

Poland · 8 centers

• Research Site — Bialystok
• Research Site — Bydgoszcz
• Research Site — Elblag
• Research Site — Lodz
• Research Site — Lodz
• Research Site — Olsztyn
• Research Site — Szczecin
• Research Site — Warsaw

Russia · 7 centers

• Research Site — Moscow
• Research Site — Moscow
• … and 5 more centers

Spain · 7 centers

Center list to be confirmed — check the primary protocol.

Turkey (Türkiye) · 6 centers

Center list to be confirmed — check the primary protocol.

Ukraine · 6 centers

Center list to be confirmed — check the primary protocol.

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 5 centers

Center list to be confirmed — check the primary protocol.

United States · 3 centers

• Research Site — Newport Beach
• Research Site — Denver
• Research Site — Memphis

Canada · 3 centers

• Research Site — Kingston
• Research Site — Newmarket
• Research Site — Toronto

Germany · 3 centers

• Research Site — Gütersloh
• Research Site — Münster
• Research Site — Oldenburg

Hungary · 3 centers

• Research Site — Budapest
• Research Site — Győr
• Research Site — Székesfehérvár

Thailand · 3 centers

Center list to be confirmed — check the primary protocol.

Vietnam · 3 centers

Center list to be confirmed — check the primary protocol.

Australia · 2 centers

• Research Site — Box Hill
• Research Site — Melbourne

Brazil · 2 centers

• Research Site — Barretos
• Research Site — São José do Rio Preto

Bulgaria · 2 centers

• Research Site — Sofia
• Research Site — Sofia

Mexico · 2 centers

• Research Site — Mexico City
• Research Site — Mérida

United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Argentina · 1 center

• Research Site — Rosario

Belgium · 1 center

• Research Site — Charleroi

Czechia · 1 center

• Research Site — Olomouc

Greece · 1 center

• Research Site — Athens

India · 1 center

• Research Site — Chennai

Malaysia · 1 center

• Research Site — Kuching

Philippines · 1 center

• Research Site — Quezon City

Romania · 1 center

• Research Site — Suceava

Switzerland · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05303532 · D4191C00137 · 2021-003031-29

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗