PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 11, 2016

Primary Completion Date

November 2, 2021

Study Completion Date

May 31, 2023

Conditions
Colorectal CancerColorectal AdenocarcinomaStage IVA Colorectal CancerStage IVB Colorectal CancerMetastatic Carcinoma in the Liver
Interventions
RADIATION

Stereotactic body radiotherapy (SBRT)

"SBRT treatment will consist of 40-60 Gy delivered in five fractions prescribed to the planning target volume (PVT). Image guidance with MRI, megavoltage CT or cone beam CT scans would be required.~SBRT will be initiated on Day 0. This should be initiated within 4 weeks of signing informed consent. An additional 2 weeks will be allowed if necessary due to SBRT treatment planning."

DRUG

Pembrolizumab

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilumumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Trial Locations (1)

53792

University of Wisconsin Carbone Cancer Center, Madison

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of Wisconsin, Madison

OTHER

NCT02837263 - PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter