Informations générales (source: ClinicalTrials.gov)
An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
février 2019
juillet 2028
12 septembre 2025
This is an open-label, multicenter, extension study. Patients who are receiving clinical
benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s)
or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored
study (the parent study), who are eligible to continue treatment and who do not have
access to the study treatment locally, may continue to receive study treatment in this
extension study following roll-over from the parent study.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Aur�lien MARABELLE | 05/06/2024 07:38:51 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - Provence Alpes COTE D'azur - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - 49933 - Angers - PAYS DE LA Loire - France | Contact (sur clinicalTrials) | ||||
| hopital de la Timone - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Eligible for continuing atezolizumab-based therapy at the time of roll-over from the
parent study, as per the parent study protocol or
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored
study as per the parent study protocol, with no access to commercially available
comparator agent
- Time between the last dose of treatment received in parent study and first dose in
extension study is no longer than the interruption period allowed in the parent
study. First dose of study treatment in this extension study will be received within
7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator
at the time of roll-over from the parent study as assessed by the investigator
- Negative serum pregnancy test within 7 days prior to start of study treatment in
women of childbearing potential
- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement
to refrain from donating sperm
- Eligible for continuing atezolizumab-based therapy at the time of roll-over from the
parent study, as per the parent study protocol or
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored
study as per the parent study protocol, with no access to commercially available
comparator agent
- Time between the last dose of treatment received in parent study and first dose in
extension study is no longer than the interruption period allowed in the parent
study. First dose of study treatment in this extension study will be received within
7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator
at the time of roll-over from the parent study as assessed by the investigator
- Negative serum pregnancy test within 7 days prior to start of study treatment in
women of childbearing potential
- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent or use contraceptive measures, and agreement
to refrain from donating sperm
- Meet any of the study treatment discontinuation criteria specified in the parent
study at the time of enrollment in this extension study
- Study treatment or comparator agent is commercially marketed in the patient's
country for the patient-specific disease and is accessible to the patient
- Treatment with any anti-cancer treatment during the time between last treatment in
the parent study and the first dose of study treatment in this extension study
- Permanent discontinuation of atezolizumab for any reason during the parent study or
during the time between last treatment in the parent study and the first dose of
study treatment in this extension study (if applicable). Exception: Participants who
permanently discontinued atezolizumab from parent studies that permit participants
to continue treatment with the combination agent(s) alone after permanently
discontinuing atezolizumab are eligible to enroll in this study.
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1
from the parent study or during the time between the last treatment in the parent
study and the first dose of study treatment in this extension study
- Any condition that, in the opinion of the investigator, would interfere with the
interpretation of patient safety or place the patient at high risk for
treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent
study)
- Pregnant or lactating, or intending to become pregnant during this extension study
and for the period after the last dose of study treatment specified in the
designated referenced safety information (RSI)