E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract |
Post-chimiothérapie du carcinome urothélial ou non-urothélial des voies urinaires |
|
E.1.1.1 | Medical condition in easily understood language |
Urinary Tract Cancer |
Cancer des voies urinaires |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061272 |
E.1.2 | Term | Malignant urinary tract neoplasm |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and tolerability. |
Fournir un approvisionnement ininterrompu en traitement expérimental aux patients qui continuent à en retirer des bénéfices à la fin d'une étude clinique, tout en évaluant la sécurité d'emploi et la tolérance
|
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Provision of signed and dated, written ICF. 2. 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. |
1 Remise d’un formulaire de consentement éclairé écrit, signé et daté. 2 De l’avis de l’investigateur, le patient ou la patiente retire actuellement un bénéfice clinique, en continuant le traitement d’une étude mère d’AZ portant sur un traitement expérimental qui a rempli les critères d’évaluation, ou qui s’est interrompue pour d’autres raisons, ou le patient ou la patiente a atteint la durée maximale de traitement autorisée dans le protocole de l’étude mère.
|
|
E.4 | Principal exclusion criteria |
Core Protocol exclusion criteria: 1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. Currently receiving treatment with any prohibited medication(s). 3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 4. Permanent discontinuation from the parent study due to toxicity or disease progression. 5. 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: 6. 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). 7. 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. 8. 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. |
Critères d'exclusion du protocole principal : 1 Toxicité en cours, non résolue, de grade 3 ou supérieur nécessitant l’interruption du traitement au moment de la fin de l’étude mère. 2 Traitement actuel par un ou plusieurs médicaments interdits. 3 Inclusion simultanée dans tout autre type de recherche médicale jugée non scientifiquement ou médicalement compatible avec cette étude. 4 Interruption définitive de la participation à l’étude mère en raison d’une toxicité ou d’une progression de la maladie. 5 Autorisation par la réglementation locale/nationale d’un accès gratuit pour le patient au médicament commercialement disponible.
Critères d'exclusion supplémentaires pour la sous-étude ROSY-D : 6 Infection active, y compris infection par la COVID-19 (confirmée par PCR et/ou suspectée cliniquement), la tuberculose, l’hépatite B (résultat AgHBs positif connu), l’hépatite C ou le VIH (anticorps VIH 1/2 positifs). 7 Patients de sexes masculin ou féminin aptes à procréer qui ne sont pas disposés à utiliser une méthode de contraception efficace à compter de l’inclusion dans l’étude et jusqu’à 90 jours après la dernière dose de durvalumab en monothérapie. 8 Toxicité de grade 2 en cours, non résolue, avec incapacité à réduire la corticothérapie à une dose ≤ 10 mg de prednisone par jour (ou équivalent) dans les 12 semaines suivant la dernière dose du traitement à l’étude ou du schéma thérapeutique de l’étude, selon les directives de modification de la dose en cas de toxicité et de TMG pour les réactions à médiation immunitaire, liées à la perfusion et non à médiation immunitaire de l’étude parente. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
SAEs reported until 90 days after the last dose of study treatment. |
EIGs signalés jusqu’à 90 jours après la dernière dose du traitement à l’étude
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study. |
Tout au long de l'étude. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Germany |
Italy |
Korea, Republic of |
United Kingdom |
United States |
France |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LSLV |
Dernière visite du dernier patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |