A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers

PHASE1CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

January 29, 2021

Study Completion Date

January 29, 2021

Conditions
Cancer
Interventions
DRUG

BBI608

Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.

DRUG

Ipilimumab

Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.

DRUG

Nivolumab

Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.

DRUG

Pembrolizumab

Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.

Trial Locations (8)

10065

Weill Cornell Medical College, New York

29605

Institute for Translational Oncology Research, Greenville

30322

Emory University Winship Cancer Institute, Atlanta

60637

University of Chicago Medicine Comprehensive Cancer Center, Chicago

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Cancer Center, Denver

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana Farber Cancer Institute, Boston

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02467361 - A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers | Biotech Hunter | Biotech Hunter