Overview

Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies

Status:
Recruiting
Trial end date:
2031-12-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients with surface accessible solid tumors for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.
Phase:
Early Phase 1
Details
Lead Sponsor:
Presage Biosciences
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Takeda
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Cisplatin
Fluorouracil
Ipilimumab
Nivolumab
Paclitaxel
Pembrolizumab