BO-112 With Pembrolizumab in Unresectable Malignant Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 30, 2020

Primary Completion Date

October 3, 2023

Study Completion Date

August 1, 2024

Conditions
Melanoma
Interventions
DRUG

BO-112 plus pembrolizumab

Patients will be treated with the combination of BO-112 and pembrolizumab. Order of administration should be pembrolizumab then IT BO-112. BO-112 will be administered IT at a total dose of 1-2 mg at each administration to 1-8 tumor lesions using tuberculin (TB) syringes (or equivalent) with 20- to 25-gauge needles

PROCEDURE

Tissue Biopsies

Pre and post (if feasible) treatment tumor tissue biopsies will be used for correlative research.

Trial Locations (19)

Unknown

Centre Hospitalier Universitaire de Bordeaux, Bordeaux

Centre Hospitalier Universitaire de Grenoble, Grenoble

Hopital Lyon Sud, Lyon

Centre Hospitalier Universitaire de Nantes, Nantes

Centre Hospitalier Universitaire de Nice, Nice

Hôpital Ambroise-Paré, Paris

Institut Gustave Roussy, Paris

H. Universitari Germans Trias i Pujol, Badalona

Hospital Universitario de Canarias, San Cristóbal de La Laguna

H. Universitari Quirón Dexeus, Barcelona

Hospital Clinic de Barcelona, Barcelona

Hospital Clara Campal - HM Sanchinarro, Madrid

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario 12 de Octubre, Madrid

MD Anderson Cancer Center, Madrid

Hospital Clínico Universitario Virgen de la Arrixaca, Murcia

Clínica Universidad de Navarra, Pamplona

Hospital Universitario Virgen Macarena, Seville

H. General Universitario de Valencia, Valencia

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Highlight Therapeutics

INDUSTRY