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

NCT01633970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-10-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633970 on ClinicalTrials.gov