NCT02323191

A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors

Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

Conditions

• Solid Cancers

Interventions

Type	Name	Description
DRUG	Atezolizumab	Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.
DRUG	Emactuzumab	Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Timeline

• Start date: 2015-01-19
• Primary completion: 2020-08-21
• Completion: 2020-08-21
• First posted: 2014-12-23
• Last updated: 2020-08-27

Locations

12 sites across 4 countries: United States, Belgium, France, Spain