Clinical trial • Phase III • Oncology
ATEZOLIZUMAB for Advanced malignancies | Locally advanced breast cancer | Ovarian cancer | Metastatic melanoma | Non-small cell lung cancer (stage IV) | Renal cell carcinoma | Squamous cell carcinoma of head and neck | Castration-resistant prostate cancer | Triple-negative breast cancer | Multiple myeloma | Metastatic colorectal cancer | Urothelial carcinoma
Phase III trial of ATEZOLIZUMAB for Advanced malignancies | Locally advanced breast cancer | Ovarian cancer | Metastatic melanoma | Non-small cell lung ca…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced malignancies | Locally advanced breast cancer | Ovarian cancer | Metastatic melanoma | Non-small cell lung cancer (stage IV) | Renal cell carcinoma | Squamous cell carcinoma of head and neck | Castration-resistant prostate cancer | Triple-negative breast cancer | Multiple myeloma | Metastatic colorectal cancer | Urothelial carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 30-05-2024
- First CTIS Authorization Date
- 08-07-2024
Trial design
open-label, none/not specified-controlled Phase III trial across 28 sites in Belgium, Czechia, France and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 1000
Eligibility
Recruits 1000 Vulnerable population selected (CTIS flag). Consent requirement: "Signed extension study Informed Consent Form" is explicitly required. No detailed information on assent procedures or specific vulnerable-subgroup consent handling is provided in the available records..
- Pregnancy Exclusion
- 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 RSI
- Vulnerable Population
- Vulnerable population selected (CTIS flag). Consent requirement: "Signed extension study Informed Consent Form" is explicitly required. No detailed information on assent procedures or specific vulnerable-subgroup consent handling is provided in the available records.
Inclusion criteria
- {"criterion_text":"- Signed extension study Informed Consent Form"}
- {"criterion_text":"- Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Able to comply with this extension study, in the investigator's judgment"}
- {"criterion_text":"- Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential"}
- {"criterion_text":"- Will comply with contraception criteria"}
Exclusion criteria
- {"criterion_text":"- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study"}
- {"criterion_text":"- Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient"}
- {"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 this 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 this extension study (if applicable) Exception: Patients who permanently discontinued atezolizumab from parent studies that permit patients to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study."}
- {"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 the last treatment in the parent study and the first dose of study treatment in this extension study"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Concurrent participation in any therapeutic clinical trial (other than the parent study)"}
- {"criterion_text":"- 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 RSI"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.","definition_or_measurement_approach":"Clinical benefit assessed by the investigator (no additional measurement approach specified in the source record)."}
Recruitment
- Planned Sample Size
- 1000
- Recruitment Window Months
- 120
- Consent Approach
- Signed extension study Informed Consent Form is required. ICFs are available in multiple languages (protocol synopses/ICFs present in German, Greek, Latvian, Russian, French, Spanish, Polish, Czech, Dutch, Romanian as per submitted documents). No specific assent procedures or age-stratified consent forms described in the available records.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 104
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 659
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- UZ Brussel
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Lore Decoster
- Contact Person Email
- lore.decoster@uzbrussel.be
- Site Name
- UZ Leuven
- Department Name
- Department of Medical Oncology
- Contact Person Name
- Oliver Bechter
- Contact Person Email
- oliver.bechter@uzleuven.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 637
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Department of Clinical Oncology
- Contact Person Name
- Alexandr Poprach
- Contact Person Email
- poprach@mou.cz
France
- Earliest CTIS Part Ii Submission Date
- 11-07-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 637
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Département d’Innovation Thérapeutiqueet Essais Précoces
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- CEPCM (Centre d’Essais Précoces en Cancérologie de Marseille)
- Contact Person Name
- Laurent Geillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 660
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Lungenfachklinik Immenhausen
- Department Name
- Pneumologische Onkologie
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- arittmeyer@lungenfachklinik-immenhausen.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Klinik für Urologie (Studienzentrale)
- Contact Person Name
- Steffen Rausch
- Contact Person Email
- steffen.rausch@med.unituebingen.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Oncology
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- studien.gauting@asklepios.com
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I, Hematology, Oncology and Stem Cell Transplantatio n
- Contact Person Name
- Cornelius Waller
- Contact Person Email
- cornelius.waller@uniklinikfreiburg.de
- Site Name
- KEM I Evang. Kliniken Essen-Mitte gGmbH
- Department Name
- Department of internal Medicine/Oncology
- Contact Person Name
- Christian Müller
- Contact Person Email
- ch.mueller@kem-med.com
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Urologie
- Contact Person Name
- Friedemann Zengerling
- Contact Person Email
- friedemann.zengerling@uniklinikulm.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department für Frauengesund heit
- Contact Person Name
- Eva-Maria Grischke
- Contact Person Email
- evamaria.grischke@med.unituebingen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Department of Dermatology
- Contact Person Name
- Evelyn Gaffal
- Contact Person Email
- evelyn.gaffal@uksh.de
Greece
- Earliest CTIS Part Ii Submission Date
- 17-09-2024
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 568
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Metropolitan Hospital
- Department Name
- 1st Dept of Oncology
- Contact Person Name
- Dimitris Bafaloukos
- Contact Person Email
- dbafaloukos@metropolitan-hospital.gr
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Bőrgyógyászati Osztály
- Contact Person Name
- Gabriella Liszkay
- Contact Person Email
- liszkay@oncol.hu
Latvia
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 661
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Rigas Austrumu kliniska universitates slimnica SIA
- Department Name
- Oncology Clinic
- Contact Person Name
- Zanete Zvirbule
- Contact Person Email
- Zanete.Zvirbule@aslimnica.lv
Poland
- Earliest CTIS Part Ii Submission Date
- 18-07-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 630
- Number Of Sites
- 7
- Number Of Participants
- 20
Sites
- Site Name
- Europejskie Centrum Zdrowia Otwock Sp. z o.o.
- Department Name
- Oddział Onkologii Klinicznej i Chemioterapii
- Contact Person Name
- Cezary Szczylik
- Contact Person Email
- badaniakliniczne@ecz-otwock.pl
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Dzienny Chemioterapii i Hematologii Onkologicznej
- Contact Person Name
- Dariusz Sawka
- Contact Person Email
- badaniadsawka@szpital-brzozow.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Chemioterapii
- Contact Person Name
- Piotr Tomczak
- Contact Person Email
- piotr.tomczak@skpp.edu.pl
- Site Name
- Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
- Department Name
- Oddział Urologii
- Contact Person Name
- Łukasz Dołowy
- Contact Person Email
- dolowy.l@dco.com.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Tkanek Miękkich, Kości I Czerniaków
- Contact Person Name
- Piotr Rutkowski
- Contact Person Email
- piotr.rutkowski@nio.gov.pl
- Site Name
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
- Department Name
- Oddział III – Chorób Płuc z Pododdziałem Onkologicznym
- Contact Person Name
- Aleksandra Szczęsna
- Contact Person Email
- aszczesna@otwock-szpital.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Ambulatorium Chemioterapii
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- Bzur1@wp.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 30-07-2024
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 637
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Medical Oncology
- Contact Person Name
- Mihai Vasile Marinca
- Contact Person Email
- marincarct@gmail.com
- Site Name
- Oncomed S.R.L.
- Department Name
- Laboratory/Research/Testing facility
- Contact Person Name
- Cristina Oprean
- Contact Person Email
- cabinet_oncomed@yahoo.com
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Medical Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- office@centruldeoncologie.ro
Slovakia
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Hospital Bratislava
- Department Name
- Clinic of Pneumology and phthisiology – Department of Clinical Oncology
- Contact Person Name
- Zuzana Svihelova
- Contact Person Email
- zuzana.svihel@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 637
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Medical oncology
- Contact Person Name
- Emiliano, Calvo Aller
- Contact Person Email
- emiliano.calvo@startmadrid.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
- codes: [3]
- Name
- Icon Clinical Research Limited
- Responsibilities
- Study documentation, Site contract negotiation and Execution, Administrator Grant Payments (and additional duties coded 1,10,12,13,5,6,8)
- Name
- Medidata Solutions Inc.
- Responsibilities
- codes: [3]
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"codes: [3]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Participant/Subject Travel, Expense and Payment Management Vendor","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: [1,10,12,13,15,5,6,8]; 15: Study documentation, Site contract negotiation and Execution, Administrator Grant Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: [3]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Novasco","duties_or_roles":"Patient reimbursement in France","organisation_type":"Pharmaceutical company"}
- {"country":"Croatia","full_name":"Optimapharm d.o.o.","duties_or_roles":"Site management","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 USE
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- 1200.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Sutent 25 mg hard capsules
- Active Substance
- SUNITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- 50.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Alectinib (Alecensa) / Alecensa 150 mg hard capsules
- Active Substance
- ALECTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1200.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Cotellic
- Active Substance
- COBIMETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 60.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- RO7047650
- Active Substance
- CABOZANTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 60 mg (maxDailyDoseAmount)
- Investigational Product Name
- Zelboraf
- Active Substance
- VEMURAFENIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 1440.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Venclexta, Venclyxto
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- 1200.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- RO7250726
- Active Substance
- NIRAPARIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- 200.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- Paclitaxel 6 mg/ml Concentrate for Solution for Infusion
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- 261.00 mg (maxDailyDoseAmount)
- Investigational Product Name
- ALIMTA 500 mg powder for concentrate for solution for infusion
- Active Substance
- PEMETREXED
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- prodAuthStatus: 2
- Maximum Dose
- 1415.00 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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