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A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors

NCT02715531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2021-07-09

No results posted yet for this study

Summary

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.

Conditions

Interventions

DRUG

5-FU

5-FU (400 mg/m\^2) will be administered as an IV bolus, followed by 2400 mg/m\^2 by continuous IV infusion over 46 (± 1) hours, q2w.

DRUG

Atezolizumab

Participants will receive atezolizumab in a flat dose of 1200 mg q3w (Arm A, Group E2, and Arm F) or 840 mg q2w (Arm B, Arm C, and Groups E1 and E3).

DRUG

Bevacizumab

Participants will receive bevacizumab at 15 mg/kg q3w (Arm A and Group F1) or 10 mg/kg q2w (Arm B).

DRUG

Gemcitabine

Gemcitabine will be administered according to the local prescribing information. The starting dose-level of gemcitabine (1000 mg/m\^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).

DRUG

Leucovorin

Leucovorin 200 mg/m\^2 L-isomer form or 400 mg/m\^2 D,L-racemic form will be administered IV over 120 (± 15) minutes, q2w.

DRUG

Nab-Paclitaxel

Nab-Paclitaxel will be administered according to the local prescribing information. The starting dose-level of nab-paclitaxel (125 mg/m\^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).

DRUG

Oxaliplatin

Oxaliplatin 85 mg/m\^2 will be administered IV over 120 (± 5) minutes q2w.

DRUG

Capecitabine

Capecitabine may be administered after 6 months at the discretion of the investigator (range of 650-1000 mg/m\^2) twice daily on Days 1-4 of a 21-day cycle.

DRUG

Cisplatin

Cisplatin will be administered as 80 mg/m\^2 IV over 120 minutes q3w (Group E2).

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-06
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States
  • Australia
  • China
  • Japan
  • New Zealand
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02715531 on ClinicalTrials.gov