A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Running, not enrolling · Phase 3

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT03768063

Run by

Hoffmann-La Roche

People needed

1000

Starts

2019-02-28

Expected to finish

2028-07-05

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Yale University School Of Medicine — Trumbull, Connecticut, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Carolina BioOncology Institute, PLCC — Huntersville, North Carolina, United States
• St. Luke's Cancer Care Associates — Bethlehem, Pennsylvania, United States
• University of Texas Health Sciences Center in San Antonio — San Antonio, Texas, United States
• St Vincent'S Hospital — Darlinghurst, New South Wales, Australia
• UZ Leuven — Leuven, Flemish Brabant, Belgium
• Institut Jules Bordet — Brussels, Belgium
• UZ Brussel — Brussels, Belgium
• Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
• Multiprofile Hospital for Active Treatment Central Onco Hospital OOD — Plovdiv, Bulgaria
• Pontificia Universidad Catolica de Chile — Santiago, Chile
• Masaryk?v onkologický ústav — Brno, Czechia
• Rigshospitalet — København Ø, Denmark
• CHU Angers — Angers, Pays de la Loire Region, France
• Centre Antoine Lacassagne — Nice, Provence-Alpes-Côte d'Azur Region, France
• Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez — Lille, France
• hopital de la Timone — Marseille, France
• Institut Gustave Roussy — Villejuif, Île-de-France Region, France
• Universitätsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
• Krankenhaus Barmherzige Bruder Regensburg — Regensburg, Bavaria, Germany
• Universitätsklinikum Schleswig-Holstein;Campus Lübeck — Lübeck, Schleswig-Holstein, Germany
• Kliniken Essen-Mitte — Essen, Germany
• University of Colorado Cancer Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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