Clinical trial • Not applicable • Oncology
Atezolizumab for Urothelial carcinoma (bladder) | Non-small cell lung cancer | Kidney cancer
Not applicable trial of Atezolizumab for Urothelial carcinoma (bladder) | Non-small cell lung cancer | Kidney cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Urothelial carcinoma (bladder) | Non-small cell lung cancer | Kidney cancer
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-01-2024
- First CTIS Authorization Date
- 14-02-2024
Trial design
open-label, comparator agent(s) per parent study (not specified in this extension record)-controlled Not applicable trial in Czechia, Hungary, Poland and others.
- Open Label
- Yes
- Comparator
- Comparator agent(s) per parent study (not specified in this extension record)
- Target Sample Size
- 239
Eligibility
Recruits 239 Vulnerable populations selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple versions listed in the trial documents). Specific details on assent or additional consent handling for vulnerable participants are not specified in the record..
- Pregnancy Exclusion
- Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential.
- Vulnerable Population
- Vulnerable populations selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are provided (multiple versions listed in the trial documents). Specific details on assent or additional consent handling for vulnerable participants are not specified in the record.
Inclusion criteria
- {"criterion_text":"- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent."}
- {"criterion_text":"- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study."}
- {"criterion_text":"- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator."}
- {"criterion_text":"- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Able to comply with the extension study, in the investigator’s judgment; Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential."}
- {"criterion_text":"- Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow-up at the time of IMpower133 parent study closure"}
- {"criterion_text":"- Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the IMpower133 parent-study closure."}
Exclusion criteria
- {"criterion_text":"- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study"}
- {"criterion_text":"- Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient."}
- {"criterion_text":"- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade<=1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study"}
- {"criterion_text":"- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study"}
- {"criterion_text":"- 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 the extension study (if applicable)"}
- {"criterion_text":"- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information"}
Endpoints
Primary endpoints
- {"endpoint_text":"- N/A (Not Applicable)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v4.0"}
- {"endpoint_text":"- Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v4.0"}
- {"endpoint_text":"- Time from randomization or treatment initiation (as indicated in parent study protocol) to death due to any cause (For patients from Impower 133 only)","definition_or_measurement_approach":"Time-to-event measured from randomization or treatment initiation as per parent-study protocol to death from any cause (applies to IMpower133 rollover patients only)"}
Recruitment
- Planned Sample Size
- 239
- Recruitment Window Months
- 149
- Consent Approach
- Subject information and informed consent forms are provided (multiple ICF/SIS documents available in the trial documents). Multiple language versions are present (examples in the documents list include French, Turkish, Polish, Hungarian, Spanish, Austrian/German versions and general/English versions). Specific assent procedures or detailed age-based consent handling are not described in the provided record.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 99
Czechia
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 30-05-2024
- Processing Time Days
- 128
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- pneumologická klinika
- Contact Person Name
- Libor Havel
- Contact Person Email
- libor.havel@ftn.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 132
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Clinic Of Pulmonology Semmelweis University
- Department Name
- Clinic of Pulmonology
- Contact Person Name
- Gyorgy Losonczy
- Contact Person Email
- losonczy.gyorgy@med.semmelweis-univ.hu
- Site Name
- Toeroekbalinti Tuedogyogyintezet
- Department Name
- Department II.
- Contact Person Name
- Eva Morocz
- Contact Person Email
- eva.morocz262@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 132
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Płuca i Klatki Piersiowej
- Contact Person Name
- Dariusz Kowalski
- Contact Person Email
- sekretariat4@nio.gov.pl
Austria
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Krankenhaus Nord Klinik Floridsdorf
- Department Name
- Department for Respiratory and Critical Care Medicine
- Contact Person Name
- Maximilian Hochmair
- Contact Person Email
- maximilian.hochmair@gesundheitsverbund.at
- Site Name
- Wiener Gesundheitsverbund
- Department Name
- Department of Respiratory and Lung Diseases
- Contact Person Name
- Marie-Kathrin Breyer
- Contact Person Email
- office.lbi.lunghealth@oncolbilh.com
France
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 16-02-2024
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 28
Sites
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Institut Gustave Roussy; Sitep
- Contact Person Name
- Capucine Baldini
- Contact Person Email
- capucine.baldini@gustaveroussy.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 19-02-2024
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 56
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Contact Person Name
- Reyes Bernabe
- Contact Person Email
- bernabeensayos@gmail.com
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Randomization
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Randomization","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised (marketing authorisation EU/1/17/1220/001)
- Maximum Dose
- 1200 mg (max daily dose amount reported)
- Combination Treatment
- Yes
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