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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) - 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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Atezolizumab Monotherapy 		Participants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
  • Drug: Atezolizumab
    Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
    Other names:
    • Tecentriq
Experimental
Combined Agents with Atezolizumab 		Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
  • Drug: Atezolizumab
    Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
    Other names:
    • Tecentriq
  • Drug: Bevacizumab
    Bevacizumab will be administered as directed per the parent study.
    Other names:
    • Avastin
  • Drug: Alectinib
    Alectinib will be administered as directed per the parent study.
    Other names:
    • Alecensa
  • Drug: Cobimetinib
    Cobimetinib will be administered as directed per the parent study.
    Other names:
    • Cotellic
  • Drug: Vemurafenib
    Vemurafenib will be administered as directed per the parent study.
    Other names:
    • Zelboraf
  • Drug: FAP IL2V
    FAP IL2V will be administered as directed per the parent study.
    Other names:
    • simlukafusp alfa
  • Drug: Venetoclax
    Venetoclax will be administered as directed per the parent study.
    Other names:
    • Venclexta
  • Drug: Enzalutamide
    Enzalutamide will be administered as directed per the parent study.
    Other names:
    • Xtandi
  • Drug: Niraparib
    Niraparib will be administered as directed per the parent study.
    Other names:
    • Zejula
  • Drug: Cabozantinib
    Cabozantinib will be administered as directed per the parent study.
    Other names:
    • Cometriq
  • Drug: Pemetrexed
    Pemetrexed will be administered as directed per the parent study.
  • Drug: Paclitaxel
    Paclitaxel will be administered as directed per the parent study.
  • Drug: Emactuzumab
    Emactuzumab will be administered as directed per the parent study.
  • Drug: Rucaparib
    Rucaparib will be administered as directed per the parent study.
Active Comparator
Comparator Treatment 		Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
  • Drug: Cobimetinib
    Cobimetinib will be administered as directed per the parent study.
    Other names:
    • Cotellic
  • Drug: Vemurafenib
    Vemurafenib will be administered as directed per the parent study.
    Other names:
    • Zelboraf
  • Drug: Venetoclax
    Venetoclax will be administered as directed per the parent study.
    Other names:
    • Venclexta
  • Drug: Enzalutamide
    Enzalutamide will be administered as directed per the parent study.
    Other names:
    • Xtandi
  • Drug: Pembrolizumab
    Pembrolizumab will be administered as directed per the parent study.
    Other names:
    • Keytruda
  • Drug: Sunitinib
    Sunitinib will be administered as directed per the parent study.
    Other names:
    • Sutent
  • Drug: Niraparib
    Niraparib will be administered as directed per the parent study.
    Other names:
    • Zejula
  • Drug: Pemetrexed
    Pemetrexed will be administered as directed per the parent study.
  • Drug: Paclitaxel
    Paclitaxel will be administered as directed per the parent study.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BO40729 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.