A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
Launched by HOFFMANN-LA ROCHE · Dec 5, 2018
Trial Information
Current as of April 30, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is an extension study for patients who have been previously enrolled in a study testing a medication called atezolizumab, which is used to treat cancer. If patients are doing well on this treatment and don't have access to it locally, they can continue receiving it in this new study. It's designed for those who have shown benefits from atezolizumab, either on its own or with other treatments, and want to keep going with it after their initial study ends.
To be eligible for this trial, you need to have been receiving treatment in the earlier study and still be benefiting from it. You also should not have access to the treatment outside of the study. The trial is open to all adults aged 65 and older, and certain conditions must be met regarding your health and treatment history. Participants can expect to continue their treatment regimen and will have regular checks to ensure their safety and progress. Importantly, this trial is currently recruiting participants, so there is an opportunity to join if you meet the criteria.
Gender
ALL
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)
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Bronx, New York, United States
Bordeaux, , France
Nice, , France
Detroit, Michigan, United States
Saint Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Boston, Massachusetts, United States
Oshawa, Ontario, Canada
Lyon, , France
Valencia, , Spain
Hong Kong, , Hong Kong
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Duarte, California, United States
Boston, Massachusetts, United States
New York, New York, United States
Barcelona, , Spain
Washington, District Of Columbia, United States
Bronx, New York, United States
Chicago, Illinois, United States
Singapore, , Singapore
Hamburg, , Germany
Aurora, Colorado, United States
Seoul, , Korea, Republic Of
Taipei City, , Taiwan
Bangkok, , Thailand
Palo Alto, California, United States
Aichi, , Japan
Bruxelles, , Belgium
Houston, Texas, United States
Townsville, Queensland, Australia
Houston, Texas, United States
New Haven, Connecticut, United States
Barcelona, , Spain
Valencia, , Spain
Fukuoka, , Japan
Okayama, , Japan
Taichung, , Taiwan
Ulm, , Germany
Heidelberg, , Germany
Villejuif, , France
Toulouse, , France
Darlinghurst, New South Wales, Australia
Leuven, , Belgium
Lutsk, , Ukraine
Port Saint Lucie, Florida, United States
Everett, Washington, United States
Saitama, , Japan
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Freiburg, , Germany
Otwock, , Poland
Bratislava, , Slovakia
Villejuif Cedex, , France
Marseille, , France
Brussel, , Belgium
Muenster, , Germany
Paris, , France
Malaga, , Spain
Los Angeles, California, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Chattanooga, Tennessee, United States
Rio De Janeiro, Rj, Brazil
Porto Alegre, Rs, Brazil
Sao Paulo, Sp, Brazil
Guatemala City, , Guatemala
Immenhausen, , Germany
Budapest, , Hungary
Fukuoka, , Japan
Bordeaux, , France
Douglas, Queensland, Australia
Niigata, , Japan
Palma De Mallorca, Islas Baleares, Spain
Hong Kong, , Hong Kong
København ø, , Denmark
Lübeck, , Germany
Camperdown, New South Wales, Australia
Scarborough, Maine, United States
Olomouc, , Czechia
Otwock, , Poland
Regensburg, , Germany
Ishikawa, , Japan
Essen, , Germany
Ehime, , Japan
Baltimore, Maryland, United States
Seoul, , Korea, Republic Of
New Haven, Connecticut, United States
Toulouse, , France
Tübingen, , Germany
Milano, Lombardia, Italy
Sabadell, Barcelona, Spain
Angers, , France
Hamburg, , Germany
New Haven, Connecticut, United States
Bellflower, California, United States
Monterrey, , Mexico
Hokkaido, , Japan
München, , Germany
København ø, , Denmark
Iasi, , Romania
Aurora, Colorado, United States
Brno, , Czechia
Tübingen, , Germany
Pecs, , Hungary
Seattle, Washington, United States
Athens, , Greece
Madrid, , Spain
Toronto, Ontario, Canada
Iasi, , Romania
Nashville, Tennessee, United States
Gera, , Germany
Tübingen, , Germany
Malvern, Victoria, Australia
Saint Mande, , France
Athens, , Greece
λαρισα, , Greece
Clermont Ferrand, , France
Budapest, , Hungary
Kraków, , Poland
Saint Petersburg, , Russian Federation
Bratislava, , Slovakia
Montpellier, , France
Ann Arbor, Michigan, United States
Chicago, Illinois, United States
Barcelona, , Spain
Frankfurt Am Main, , Germany
Otwock, , Poland
Olomouc, , Czechia
Taipei, , Taiwan
Fort Myers, Florida, United States
Szeged, , Hungary
Gera, , Germany
Trumbull, Connecticut, United States
Milano, Lombardia, Italy
New York, New York, United States
Osaka, , Japan
Gdańsk, , Poland
Olsztyn, , Poland
Lille, , France
Warszawa, , Poland
Vancouver, British Columbia, Canada
Paris, , France
Madrid, , Spain
Sakai Shi, , Japan
Heilbronn, , Germany
London, , United Kingdom
Budapest, , Hungary
Miami, Florida, United States
Konin, , Poland
Bethlehem, Pennsylvania, United States
Toulon, , France
Kanagawa, , Japan
Moscow, , Russian Federation
Lugo, , Spain
Putzu, , Taiwan
Kharkiv, Kharkiv Governorate, Ukraine
Kryvyi Rih, , Ukraine
Lviv, Volhynian Governorate, Ukraine
Orlando, Florida, United States
Gauting, , Germany
Athens, , Greece
Larissa, , Greece
Poznan, , Poland
Arkhangelsk, Arhangelsk, Russian Federation
Iwate, , Japan
Moscow, , Russian Federation
Scottsdale, Arizona, United States
Ibaraki, , Japan
Fribourg, , Switzerland
Craiova, , Romania
Saint Petersburg, Florida, United States
St. Petersburg, Sankt Petersburg, Russian Federation
Dnipropetrovsk, Katerynoslav Governorate, Ukraine
Vinnytsia, Podolia Governorate, Ukraine
Pamplona, Navarra, Spain
London, , United Kingdom
Madrid, , Spain
Saint Petersburg, , Russian Federation
Boston, Massachusetts, United States
Little Rock, Arkansas, United States
Gyeonggi Do, , Korea, Republic Of
Chermside, Queensland, Australia
Poznań, , Poland
Bydgoszcz, , Poland
Charlotte, North Carolina, United States
Budapest, , Hungary
Seoul, Gangnam Gu, Korea, Republic Of
Tübingen, , Germany
Sofia, , Bulgaria
Porto, , Portugal
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Barcelona, Barcelona [Barcelona], Spain
Kiev, , Ukraine
Cluj Napoca, , Romania
Yangsan, , Korea, Republic Of
San Antonio, Texas, United States
Førde, , Norway
Toulouse, , France
Ivanovo, , Russian Federation
Singapore, , Singapore
Mexico City, , Mexico
Seoul, Seoul, Korea, Korea, Republic Of
Marseille, , France
Bytom, , Poland
Santiago, Metropolitana, Chile
Palma De Mallorca, Palma De Mallorca(baleares), Spain
Birmingham, Alabama, United States
North Haven, Connecticut, United States
Trumbull, Connecticut, United States
Fort Wayne, Indiana, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Gent, , Belgium
Goiania, Go, Brazil
Plovdiv, , Bulgaria
Santiago, , Chile
Freiburg, , Germany
Immenhausen, , Germany
Athens, , Greece
Budapest, , Hungary
Budapest, , Hungary
Gyor, , Hungary
Szeged, , Hungary
Szekesfehervar, , Hungary
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Riga, , Latvia
Toluca De Lerdo, , Mexico
Timisoara, , Romania
Ivanovo, , Russian Federation
Bratislava, , Slovakia
Madrid, , Spain
Madrid, , Spain
Uzhhorod, Kiev Governorate, Ukraine
Sumy, , Ukraine
Marseille, , France
San Diego, California, United States
Winter Park, Florida, United States
Charlotte, North Carolina, United States
Olsztyn, , Poland
Kryvyi Rih, , Ukraine
Brno, , Czechia
Kraków, , Poland
Gda?Sk, , Poland
Porto, , Portugal
Pozna?, , Poland
Vancouver, British Columbia, Canada
Brzozów, , Poland
Goiania, Go, Brazil
Warszawa, , Poland
Madrid, , Spain
Warszawa, , Poland
Madrid, , Spain
St Petersburg, Sankt Petersburg, Russian Federation
Saint Petersburg, Sankt Petersburg, Russian Federation
Moscow, Moskovskaja Oblast, Russian Federation
Nashville, Tennessee, United States
Monterrey, Nuevo Leon, Mexico
Moscow, Moskovskaja Oblast, Russian Federation
Valencia, , Spain
Bydgoszcz, Kujawsko Pomorskie, Poland
Gdansk, , Poland
Larissa, , Greece
Nashville, Tennessee, United States
Piraeus, Attica, Greece
Detroit, Maine, United States
Bratislava, , Slovakia
Chattanooga, Tennessee, United States
Miyagi, , Japan
Leipzig, , Germany
Sakai Shi, , Japan
Sao Paulo, São Paulo, Brazil
Rio De Janeiro, , Brazil
Olsztyn, , Poland
Goiania, Goiás, Brazil
Kryvyi Rih, , Ukraine
Moscow, Moskovskaja Oblast, Russian Federation
Brno, , Czechia
Bangkok, , Thailand
Porto Alegre, Rio Grande Do Sul, Brazil
Kharkiv, Kharkiv Governorate, Ukraine
Bytom, , Poland
Cluj Napoca, , Romania
Fort Wayne, Indiana, United States
Plovdiv, , Bulgaria
Gauting, , Germany
Leipzig, , Germany
Pecs, , Hungary
Szekesfehervar, , Hungary
Seoul, , Korea, Republic Of
Riga, , Latvia
Toluca De Lerdo, , Mexico
Pozna?, Wielkopolskie, Poland
Sabadell, Barcelona, Barcelona, Spain
Pamplona/Iruña, Navarra, Spain
Fribourg, , Switzerland
Vinnytsia, Podolia Governorate, Ukraine
Sumy, , Ukraine
Maitland, Florida, United States
Nice, Provence Alpes Cote D'azur, France
Regensburg, Bayern, Germany
Wroc?Aw, , Poland
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials