Completed

An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985 (Vanucizumab), and in Combination With Atezolizumab, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors

What is being tested

Vanucizumab

+ Atezolizumab [TECENTRIQ]

+ Vanucizumab

Biological

Who is being recruted

Neoplasms

Over 18 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: October 2012

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: October 5, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: October 31, 2012

Actual date on which the first participant was enrolled.

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.

NCT01688206

Principal SponsorHoffmann-La Roche

Last updated: October 5, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

132 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

12 inclusion criteria required to participate

Adequate cardiovascular function

Adequate coagulation

Adequate hematological function

Adequate liver function

Show More Criteria

16 exclusion criteria prevent from participating

Administration of a live, attenuated vaccine within 4 weeks before Cycle1 Day1 or anticipation that such a live attenuated vaccine will be required during the study

Any prior radiotherapy to the pelvis or abdomen

Chronic daily treatment with non-steroidal anti-inflammatory drug (NSAID) (occasional use for the symptomatic relief of medical conditions, for example, headache, fever is allowed)

History of autoimmune disease including, but not limited to systemic lupus erythematosus (SLE), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, systemic immune activation, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barré syndrome, Bell's palsy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants will receive escalating doses of vanucizumab and fixed dose of vanucizumab, intravenously every 2 weeks.

Group II

Experimental

Participants will receive fixed dose of vanucizumab along with atezolizumab, intravenously every 2 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Cliniques Universitaires St-Luc

Brussels, BelgiumOpen Cliniques Universitaires St-Luc in Google Maps

UZ Leuven Gasthuisberg

Leuven, Belgium

Institut Bergonie; Oncologie

Bordeaux, France

Centre Francois Baclesse; Oncologie

Caen, France

Completed14 Study Centers