drugset / Trial / NCT01633970

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

NCT01633970

Phase 1 Completed 240 enrolled Genentech, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-07-11
Primary completion
2020-02-26
Completion
2020-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 800 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Carboplatin Small molecule Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous

Indications