Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

January 2, 2024

Study Completion Date

April 29, 2026

Conditions
Metastatic Distal Bile Duct AdenocarcinomaMetastatic Gallbladder CarcinomaMetastatic Intrahepatic CholangiocarcinomaRecurrent Distal Bile Duct AdenocarcinomaRecurrent Gallbladder CarcinomaRecurrent Intrahepatic CholangiocarcinomaStage IV Distal Bile Duct Cancer AJCC v8Stage IV Gallbladder Cancer AJCC v8Stage IV Intrahepatic Cholangiocarcinoma AJCC v8Unresectable Liver Carcinoma
Interventions
BIOLOGICAL

Atezolizumab

Given IV

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cobimetinib

Given PO

PROCEDURE

Computed Tomography

Undergo a CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Varlilumab

Given IV

Trial Locations (29)

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

14263

Roswell Park Cancer Institute, Buffalo

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

27157

Wake Forest University Health Sciences, Winston-Salem

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33176

UM Sylvester Comprehensive Cancer Center at Kendall, Miami

33180

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura

33324

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation

33442

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

37232

Vanderbilt University/Ingram Cancer Center, Nashville

43210

Ohio State University Comprehensive Cancer Center, Columbus

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

55905

Mayo Clinic in Rochester, Rochester

60611

Northwestern University, Chicago

77030

M D Anderson Cancer Center, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

80045

UCHealth University of Colorado Hospital, Aurora

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

85054

Mayo Clinic Hospital in Arizona, Phoenix

90033

Los Angeles General Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

91010

City of Hope Comprehensive Cancer Center, Duarte

92868

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

95817

University of California Davis Comprehensive Cancer Center, Sacramento

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH