A Study of Vanucizumab (RO5520985) Alone or in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Sponsor
Hoffmann-La Roche
Study ID
NCT01688206
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

  • Atezolizumab [TECENTRIQ] — BIOLOGICAL
    Participants will receive atezolizumab at a fixed dose of 840 mg, intravenously every 2 weeks.
  • Vanucizumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2012
Status verified
Oct 2018
Primary completion
Dec 2, 2016
Completion
Mar 12, 2018

Study Design

Enrollment
132 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vanucizumab
    Participants will receive escalating doses of vanucizumab and fixed dose of vanucizumab, intravenously every 2 weeks.
  • Experimental: Vanucizumab + Atezolizumab
    Participants will receive fixed dose of vanucizumab along with atezolizumab, intravenously every 2 weeks.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Vanucizumab [ Time Frame: approximately 28 days ]

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