Study of BO-112 With Pembrolizumab for Colorectal or Gastric/GEJ Cancer With Liver Metastasis

PHASE2TerminatedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 17, 2020

Primary Completion Date

December 2, 2022

Study Completion Date

December 2, 2022

Conditions
Colorectal CancerGastric CancerOesophageal Cancer
Interventions
PROCEDURE

Hepatic Biopsy

In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.

DRUG

BO-112 with pembrolizumab

BO-112 was administered in the liver metastasis at the dose of 1mg (1.2 mL) in combination with intravenous pembrolizumab given at the fixed dose of 200 mg, every 3 weeks for up to 35 cycles (2 years). During the first cycle, BO-112 was administered on D1 and D8.

Trial Locations (12)

Unknown

Institut Jules Bordet, Brussels

UCL St-Luc, Brussels

University Hospital Antwerp (UZA), Edegem

Universitair Ziekenhus Gent, Ghent

IRCCS Ospedale Policlinico San Martino, Genova

Azienda Ospedaliera Ospedale Niguarda Ca'Granda, Milan

Hospital Reina Sofía, Córdoba

Hospital Valle Hebrón, Barcelona

Hospital Gregorio Marañón, Madrid

Hospital Ramón y Cajal, Madrid

Clínica Universitaria de Navarra, Pamplona

Hospital Clínico de Valencia, Valencia

Sponsors
All Listed Sponsors
lead

Highlight Therapeutics

INDUSTRY