Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Deborah Wong (ucla)

Description

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 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.

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)

Keywords

Cancer, Bevacizumab, Pembrolizumab, Pemetrexed, Atezolizumab, Sunitinib, Venetoclax, Niraparib, Vemurafenib, Rucaparib, Alectinib, Cobimetinib, FAP IL2V, Enzalutamide, Cabozantinib, Paclitaxel, Emactuzumab, Atezolizumab Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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)
  • 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)

Locations

  • UCLA Hematology / Oncology Clinic in progress, not accepting new patients
    Los Angeles California 90095 United States
  • Kaiser Permanente - Bellflower withdrawn
    San Diego California 92108 United States
  • Stanford University Medical Center withdrawn
    Palo Alto California 94304 United States
  • City of Hope withdrawn
    Duarte California 91010 United States
  • Advent Health Orlando accepting new patients
    Orlando Florida 32804 United States
  • Nagoya University Hospital accepting new patients
    Aichi 466-8560 Japan
  • National Hospital Organization Shikoku Cancer Center accepting new patients
    Ehime 791-0280 Japan
  • National Hospital Organization Kyushu Medical Center in progress, not accepting new patients
    Fukuoka 810-8563 Japan
  • Kyushu University Hospital accepting new patients
    Fukuoka 812-8582 Japan
  • Hokkaido University Hospital accepting new patients
    Hokkaido 060-8648 Japan

Lead Scientist at University of California Health

  • Deborah Wong (ucla)
    HS Associate Clinical Professor, Medicine. Authored (or co-authored) 28 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03768063
Phase
Phase 3 Cancer, General Research Study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated