A Study of Vanucizumab (RO5520985) Alone or in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT01688206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2018-10-05
Summary
This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose \[RP2D\]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.
Conditions
- Neoplasms
Interventions
- BIOLOGICAL
-
Atezolizumab [TECENTRIQ]
Participants will receive atezolizumab at a fixed dose of 840 mg, intravenously every 2 weeks.
- BIOLOGICAL
-
Vanucizumab
Participants will receive escalating doses of vanucizumab (starting dose: 3 milligram \[mg\] per kilogram) and fixed dose of vanucizumab (MTD/RP2D: 30 mg/kg), intravenously every 2 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2016-12-02
- Completion
- 2018-03-12
Countries
- Belgium
- France
- Spain
Study Locations
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