NCT01633970

A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase Ib Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Bevacizumab and/or Chemotherapy in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, Phase Ib study that has six treatment arms is designed to assess the safety, pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered anti-programmed death-ligand 1 \[PDL1\] antibody) administered with bevacizumab (Arm A) and with bevacizumab plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (FOLFOX) (Arm B), with carboplatin and paclitaxel (Arm C), with carboplatin and pemetrexed (Arm D), with carboplatin and nab-paclitaxel (Arm E), and with nab-paclitaxel (Arm F) in participants with locally advanced or metastatic solid tumors. The study includes dose escalation cohort for establishing the maximum tolerated dose (MTD) or maximum administered dose (MAD) and then expansion cohort will be initiated based on a selected dose level at or below the MTD or MAD.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	5-FU	Participants will receive 5-FU 400 mg/m\^2 IV q2w.
DRUG	Atezolizumab	Participants will receive IV atezolizumab (800 mg q2w or 1200 mg q3w) q3w.
DRUG	Bevacizumab	Participants will receive bevacizumab 10 mg/kg or 15 mg/kg IV q3w.
DRUG	Carboplatin	Participants will receive carboplatin IV q3w with target AUC of 6 mg/mL.
DRUG	Leucovorin	Participants will receive leucovorin 400 mg/m\^2 IV q2w.
DRUG	Nab-paclitaxel	Participants will receive nab-paclitaxel 100 mg/m\^2 IV qw.
DRUG	Oxaliplatin	Participants will receive oxaliplatin 85 mg/m\^2 IV q2w.
DRUG	Paclitaxel	Participants will receive paclitaxel 200 mg/m\^2 IV q3w.
DRUG	Pemetrexed	Participants will receive pemetrexed 500 mg/m\^2 IV q3w.

Timeline

• Start date: 2012-07-11
• Primary completion: 2020-02-26
• Completion: 2020-02-26
• First posted: 2012-07-06
• Last updated: 2020-10-08

Locations

11 sites across 1 country: United States