Clinical trial NCT03768063: A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
timeFrame: Day 1 up to maximum 10 years
Secondary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
timeFrame: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
measure: Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0
timeFrame: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
measure: Treatment Duration
timeFrame: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
measure: Total Dose Received
timeFrame: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
measure: Number of Treatment Cycles
timeFrame: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Trumbull
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Maitland
country: United States
facility: Advent Health Orlando
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Huntersville
country: United States
facility: Carolina BioOncology Institute, PLCC
state: North Carolina
city: Bethlehem
country: United States
facility: St. Luke's Cancer Care Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center in San Antonio
state: Texas
city: Darlinghurst
country: Australia
facility: St Vincent'S Hospital
state: New South Wales
city: Leuven
country: Belgium
facility: UZ Leuven
state: Flemish Brabant
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge
state: Goiás
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: Rio Grande Do Sul
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: Brno
country: Czechia
facility: Masaryk?v onkologický ústav
city: København Ø
country: Denmark
facility: Rigshospitalet
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
state: Ile-de-france
city: Angers
country: France
facility: CHU Angers
state: PAYS DE LA Loire
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Provence Alpes COTE D'azur
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
city: Marseille
country: France
facility: hopital de la Timone
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-wuerttemberg
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder Regensburg
state: Bayern
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Gauting
country: Germany
facility: Asklepios-Fachklinik Muenchen-Gauting
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Hamburg
country: Germany
facility: HOPA MVZ GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Tübingen
country: Germany
facility: Universitaets-Hautklinik Tuebingen
city: Tübingen
country: Germany
facility: Universitaettsklinikum Tübingen
city: Tübingen
country: Germany
facility: Universitätsklinik Tübingen
city: Piraeus
country: Greece
facility: Metropolitan Hospital
state: Attica
city: Athens
country: Greece
facility: Laiko General Hospital Athen
city: Athens
country: Greece
facility: Anticancer Hospital Ag. Savas
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
state: Lombardia
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Osaka Habikino Medical Center
city: Sakai-shi
country: Japan
facility: NHO Kinki-Chuo Chest Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine, Liver Research Institute
city: Toluca de Lerdo
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy
state: Kujawsko-pomorskie
city: Pozna?
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
state: Wielkopolskie
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
city: Pozna?
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy
city: Wroc?aw
country: Poland
facility: Dolnoslaskie Centrum Onkologii
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: Timisoara
country: Romania
facility: Centrul de Oncologie Oncohelp
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
state: Arhangelsk
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. N.N. Blokhin
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: P.A. Herzen Oncological Inst.
state: Moskovskaja Oblast
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron Dexeus
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra-Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: Kharkiv
country: Ukraine
facility: Communal Non profit Enterprise Regional Center of Oncology
state: Kharkiv Governorate
city: Kiev
country: Ukraine
facility: National Cancer Institute MOH of Ukraine
city: Kryvyi Rih
country: Ukraine
facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncology Dispensary
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: