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

PHASE1CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

April 6, 2016

Primary Completion Date

May 31, 2021

Study Completion Date

May 31, 2021

Conditions
Solid Tumor
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).

Trial Locations (30)

112

Taipei Veterans General Hospital, Taipei

1023

Auckland City Hospital, Auckland

3084

Austin Hospital, Heidelberg

3168

Monash Medical Centre Clayton, Clayton

10002

National Taiwan University Hospital, Taipei

10027

Columbia University Medical Center, New York

13605

Seoul National University Bundang Hospital, Seongnam-si

20007

Georgetown University Medical Center, Washington D.C.

27514

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke Cancer Institute, Durham

37203

Sarah Cannon Research Inst., Nashville

40402

China Medical University Hospital, North Dist.

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic, Rochester

70457

National Cheng Kung University Hospital, Tainan City

80045

University of Colorado Hospital, Aurora

94305

Stanford Cancer Institute; Hematology, Palo Alto

210002

The 81st Hospital of P.L.A., Nanjing

06510

Yale School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

277-8577

National Cancer Center Hospital East, Chiba

232-0024

Yokohama City University Medical Center, Kanagawa

241-8515

Kanagawa Cancer Center, Kanagawa

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06531

Samsung Medical Center, Seoul

00333

Chang Gung Medical Foundation - LINKOU; Dept of Cardiology, Taoyuan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02715531 - A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or Other Treatments in Participants With Solid Tumors | Biotech Hunter | Biotech Hunter