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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Hoffmann-La Roche
Study ID
NCT03768063
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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).
  • Bevacizumab — DRUG
    Bevacizumab will be administered as directed per the parent study.
  • Alectinib — DRUG
    Alectinib will be administered as directed per the parent study.
  • Cobimetinib — DRUG
    Cobimetinib will be administered as directed per the parent study.
  • Vemurafenib — DRUG
    Vemurafenib will be administered as directed per the parent study.
  • FAP IL2V — DRUG
    FAP IL2V will be administered as directed per the parent study.
  • Venetoclax — DRUG
    Venetoclax will be administered as directed per the parent study.
  • Enzalutamide — DRUG
    Enzalutamide will be administered as directed per the parent study.
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered as directed per the parent study.
  • Sunitinib — DRUG
    Sunitinib will be administered as directed per the parent study.
  • Niraparib — DRUG
    Niraparib will be administered as directed per the parent study.
  • Cabozantinib — DRUG
    Cabozantinib will be administered as directed per the parent study.
  • Pemetrexed — DRUG
    Pemetrexed will be administered as directed per the parent study.
  • Paclitaxel — DRUG
    Paclitaxel will be administered as directed per the parent study.
  • Emactuzumab — DRUG
    Emactuzumab will be administered as directed per the parent study.
  • Rucaparib — DRUG
    Rucaparib will be administered as directed per the parent study.

Study Details

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 Dates

Start date
Feb 28, 2019
Status verified
Apr 2026
Primary completion
Jul 5, 2028
Completion
Jul 5, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) [ Time Frame: Day 1 up to maximum 10 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado80045-
Yale University School Of MedicineTrumbullConnecticut06611-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Carolina BioOncology Institute, PLCCHuntersvilleNorth Carolina28078-
St. Luke's Cancer Care AssociatesBethlehemPennsylvania18015-
University of Texas Health Sciences Center in San AntonioSan AntonioTexas78229-

Find similar trials in Aurora, CO

By research site
University of Colorado Cancer Center· Aurora, COYale University School Of Medicine· Trumbull, CTBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MACarolina BioOncology Institute, PLCC· Huntersville, NCSt. Luke's Cancer Care Associates· Bethlehem, PA

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