A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT02410512
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

Study Details

This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.

Key Dates

Start date
Apr 24, 2015
Status verified
Mar 2022
Primary completion
Nov 22, 2019
Completion
Nov 22, 2019

Study Design

Enrollment
610 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: MOXR0916 + Atezolizumab
    Cohorts of at least 3 participants each will be treated at escalating doses of MOXR0916 in combination with a fixed dose of atezolizumab to determine the MTD or maximum administered dose (MAD).
  • Experimental: Expansion: MOXR0916 + Atezolizumab
    Approximately 250-580 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, pharmacokinetic variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + atezolizumab in different cancer types.

Primary Outcome Measure

Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Days (D) 1-21 of Cycle (C) 1 (cycle = 21 days); up to D42 if extended monitoring warranted ]

Locations (9)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - BisgroveScottsdaleArizona85258-
University of ColoradoAuroraColorado80045-2517-
Yale School of MedicineNew HavenConnecticut06510-
Georgetown University Medical Center Lombardi Cancer CenterWashington D.C.District of Columbia20007-
University Of Chicago Medical Center; Section Of Hematology/OncologyChicagoIllinois60637-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Can InsBostonMassachusetts02215-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Institute - Bisgrove· Scottsdale, AZUniversity of Colorado· Aurora, COYale School of Medicine· New Haven, CTGeorgetown University Medical Center Lombardi Cancer Center· Washington D.C., DCUniversity Of Chicago Medical Center; Section Of Hematology/Oncology· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MA

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