Combination Study of SV-BR-1-GM With Retifanlimab

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 16, 2018

Primary Completion Date

November 3, 2025

Study Completion Date

November 30, 2028

Conditions
Breast CancerBreast NeoplasmMetastatic Breast CancerBreast Cancer Metastatic
Interventions
BIOLOGICAL

SV-BR-1-GM

SV-BR-1-GM inoculation intradermally at 4 sites.

DRUG

Low dose cyclophosphamide

Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.

DRUG

Interferon Inoculation

Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation.

DRUG

retifanlimab

retifanlimab 375mg administered as an intravenous infusion over 30-60 minutes every 3 weeks per randomization

Trial Locations (14)

10016

Manhattan Hematology Oncology Associates (MHOA), Manhattan

20817

The Center for Cancer and Blood Disorders a division of American Oncology Partners MD, Bethesda

22408

Hematology-Oncology Associates of Fredericksburg, Inc, Fredericksburg

32224

Mayo Clinic Florida, Jacksonville

33324

University of Miami/Sylvester at Plantation, Plantation

59102

St Vincent-Frontier Cancer Center, Billings

61801

Carle Cancer Institute, Urbana

67214

Cancer Center of Kansas (CCK), Wichita

68130

Nebraska Cancer Specialists, Omaha

75230

Mary Crowley Cancer Research, Dallas

77598

Tranquil Clinical Research, Webster

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

95403

St. Joseph Heritage Healthcare, Santa Rosa

07901

Overlook Medical Center Oncology Research, Atlantic Health System, Summit

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

LumaBridge

INDUSTRY

lead

BriaCell Therapeutics Corporation

INDUSTRY